Detachable medical tube connector

Abstract

A detachable medical tubing connector 10 for joining two sections of medical tubing includes a pump-side member 12 and a patient-side member 14 positioned axially opposite the pump-side member 12. The patient-side member 12 has a first channel 26 disposed within the pump-side member 12 and a first valve 20 disposed within the first channel 26. The pump-side member 12 has a second channel disposed within the patient-side member 14 and a second valve 22 disposed within the second channel. The first valve 20 can be an active valve and the second valve 22 can be a passive valve. A fixing bar can be provided on the pump-side member 12 and a fixing arm on the patient-side member 14 to provide a detachable coupling between the two members.

Description

Connecting the medical tube detached Technical field This disclosure generally refers to connectors for medical tubing for intravenous use. More specifically, this disclosure refers to self-sealing intravenous line connectors. Previous technique The use of medical tubing for fluid transfer to and from a patient is common practice in medical settings. Intravenous technologies and techniques have advanced so much that many devices associated with IV administration are discreet and often forgotten by the patient. Therefore, it is not uncommon for a patient attempting to move to be restricted by the tubing and the devices attached to its ends. This often causes discomfort, pain, and even danger to the patient, as it can injure the access point to the vein. This can result in deep abrasions, tears, and even hemorrhage. This is especially dangerous if the access point is a vein, artery, or vital organ. When an access point is compromised by an accidental movement, it can create an unsanitary and hazardous environment. The patient may experience bleeding, and fluids collected or administered into the patient will tend to spill from storage containers. A patient may panic and attempt to reconnect the line, which can be dangerous due to the risk of contamination. This can pose an extreme risk to the patient, and the patient is not trained to perform this task. The line, the insertion site, and the fluids may have become contaminated when the line becomes dislodged. If the patient is able to reconnect it, they could potentially introduce pathogens and other contaminants directly into the body. This can lead to serious and life-threatening infections, as well as other severe complications. US2009200796 discloses a quick-release coupling that includes a male subassembly comprising a first spring-loaded valve and two seals; and a female subassembly comprising a second spring-loaded valve and two hollow sealing elements by means of which, by actuating the seals through the sealing elements, the male and female subassemblies are securely assembled together, thereby opening both valves to allow the passage of fluid. US2006129109 discloses an optimized disconnect device suitable for use with an intravenous tube or other medical tubing device that can be manually or automatically disconnected by applying an axial force low enough to avoid injury to the patient; that can be sterilely reconnected after disconnection; that allows fluid flow in either direction; that shuts off fluid flow from both directions when disconnected; and that can be easily and economically manufactured and assembled using techniques common in injection molding processes and the medical device manufacturing industry. US2017067586 discloses a detachable connecting apparatus that joins a first pipe section to a second pipe section, including a first element and a second element positioned axially opposite the first element. The second element includes a male portion extending from the second element. A housing is disposed between the first and second elements, including a shaped socket to receive the male portion of the second element. An axial passage provides a defined flow path within the housing between the first and second elements. A stem is disposed in the axial passage between the first and second elements. A first valve is disposed in either the first or second element, and the stem engages the first valve and opens the first valve to permit flow between the first and second elements through the axial passage when the male portion of the second element is fully received in the socket of the housing. EP2736584 discloses a coupling apparatus comprising a first component having a first non-mechanical valve, a second component having a second non-mechanical valve, and a third component having a first end that mates with the first valve and a second end that mates with the second valve. The third component has an elongated orifice such that when the first end is coupled to the first valve and the second end is coupled to the second valve, a passage is defined through it. The coupling apparatus includes a detachable portion disposed between the third component and the second component, and the first and second valves close automatically when the first and second components are separated from each other. US5820614 discloses a disconnect device for placement in a medical tubing assembly that includes a first portion with a first passage through it having a first valve. While the first valve is diverted in a normally closed position to close the first passage, it is operative in an open position. The disconnect device has a second portion with a second passage containing a second valve. The second valve is also diverted in a normally closed position to close the second passage and is also operative in an open position. The second portion is releasably attached to the first, connecting the first and second passages in fluid communication, to overcome the divert of the first and second valves, open the valves, and allow fluid to flow through the device.When a preselected force, less than that required to physically separate a medical access device connected to the tubing assembly, is applied to the second portion, it detaches from the first portion. This detachment leaves the first and second valves operative in their normally closed positions, substantially impeding fluid flow from the fluid reservoir to the medical access device. What is needed then are improvements in devices and methods to prevent accidental removal of intravenous insertion points and detachable connectors for medical tubing. Summary of the invention The invention is defined by the appended independent claim, while the dependent claims describe optional features. This brief summary is intended to present, in a simplified manner, a selection of concepts that are described later in the detailed description. This summary is not intended to identify the key or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. One aspect of the disclosure is a detachable connector device for placement between two pieces of medical tubing. Commonly in current medical practice, a device or tube is inserted into the patient, and upon exiting the patient's body, it features a connector for attaching an external piece of tubing. This external tubing is a secondary container for infusion fluid, or a container for fluid withdrawal, sometimes with a pumping mechanism along the tubing between the container and the patient. The connection point between these respective segments of medical tubing is of paramount importance, as it represents a potential entry point for pathogens and is usually located very close to the patient and, therefore, near the insertion site. This disclosure allows for a fluid-sealed connection between the two connecting pieces of the medical tubing, but permits separation of the tubing sections once a specific stress threshold or range of thresholds is applied, before the adhesive or fixation devices fail, ultimately preventing the adverse event of premature device removal. The two ends of the devices, which remain attached to their respective sides of the tubing, serve as protective barriers against external pathogens and also occlude fluid flow to prevent leakage of fluids away from the patient or, ultimately, from the containers. The devices can only be attached using a special tool capable of accessing the fixation mechanism within the device. Many other objects, advantages, and features of the present disclosure will be readily apparent to those skilled in the art after observing the following drawings and the description of a preferred embodiment. Brief description of the drawings FIG. 1 is a view of an embodiment of an example apparatus in use. FIG. 2 is a view of an embodiment of an example apparatus after separation while in use. FIG. 3 is a perspective view of an embodiment of an example apparatus. FIG. 4 is a sectional side view of an embodiment of an example apparatus. FIG. 5 is a front view of an example pump-side element having a first valve arranged in the pump-side element. FIG. 6 is a front view of an example patient-side element having a second valve arranged in the patient-side element FIG. 7 is a sectional side view of an example embodiment of a first valve disposed in a pump-side element. FIG. 8 is a sectional side view of an example embodiment of a second valve disposed in a patient-side element. FIG. 9 is a perspective view of an example embodiment of a pump-side element and a patient-side element when they are uncoupled. FIG. 10 is a sectional perspective view of an example embodiment of a pump-side element and a patient-side element when they are uncoupled. FIG. 11 is an exploded perspective view of an example embodiment of an apparatus. Figure 12 is a sectional side view of an example embodiment of an anti-reconnection device. Figure 13 is a sectional perspective view of an example embodiment of a guide slot device. FIG. 14 is a sectional perspective view of an example embodiment of a guide slot device coupled to an anti-reconnection device. Figure 15 is a sectional side view of an example embodiment of a pump-side element. Figure 16 is a sectional perspective view of an example embodiment of a press-fit connector. FIG. 17a-f is a sectional side view of an embodiment of a press-fit connector and an anti-reconnection device when an axial force is applied to the apparatus. FIG. 18a-f is a close-up sectional side view of an embodiment of a press-fit connector and an anti-reconnection device while an axial force is applied to the apparatus. Modes of realizing the invention Although the execution and use of the various embodiments of the present invention are discussed in detail in this description, it should be appreciated that the present invention provides many applicable inventive concepts that materialize in a wide variety of specific contexts. The specific embodiments set forth herein are merely illustrative of particular ways of executing and using the invention and do not limit its scope. Those skilled in the art will recognize numerous equivalents to the specific apparatus and methods described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims. For clarity, not all reference numbers are included in each drawing. Furthermore, positional terms such as "top," "bottom," "side," "up," "down," etc., refer to the apparatus when it is in the orientation shown in the image, or as otherwise described. A person skilled in the art will recognize that the apparatus may assume different orientations when in use. With reference to the drawings, FIG. 1 illustrates an example application of a patient safety disconnect, or detachable medical tubing connector (device) 10, disposed in a medical tubing line. The device 10 can be used in any suitable medical line for the administration, withdrawal, or monitoring of gases, fluids, or solids, such as an intravenous (IV) line. In some embodiments, the device 10 includes a pump-side element 12 and a patient-side element 14. The device 10 is configured to disengage such that the pump-side element 12 and the patient-side element 14 separate if a threshold amount of pulling force is applied in opposite axial directions along the device 10. As seen in FIG. 1, an administration point 100, such as a catheter or other intravenous needle device, is placed in a patient 102.A first track 104 extends between apparatus 10 and a source or reservoir of fluid, gas, or solid material moving through the track. The first line 104 has a free end coupled to the apparatus 10. A second line 106 extends between the apparatus 10 and an administration point 100. The second line 106 is coupled at a free end to the apparatus 10. When the pump-side element 12 and the patient-side element 14 are coupled, one or more valves within the apparatus 10 open to allow fluid, gas, and / or solid material to pass through the apparatus 10 between the first line 104 and the second line 106. In the event that the patient 102 moves in a manner that exerts a threshold pulling force on the first and second lines 104, 106, the apparatus 10 can be separated so that the pump-side element 12 disengages from the patient-side element 14, as shown in FIG. 2.One or more valves of the apparatus 10 can be closed after the decoupling of the pump-side and patient-side elements 12, 14 so as to prevent the flow of fluid, gas, or solid material from each pump-side and patient-side element 12, 14. In some embodiments, the apparatus 10 is designed so that the level of pulling force required to cause the pump-side and patient-side elements 12, 14 to uncouple is low enough to facilitate uncoupling of the apparatus 10 before inadvertent removal of the administration point 100 from the patient 102. With regard to FIG. 3, in some embodiments the apparatus 10 includes a pump-side element 12 and a patient-side element 14 located axially opposite the pump-side element 12. In some embodiments, the pump-side element 12 includes a first connector 13. The first connector 13 may include any suitable tube or hose connector configured to attach to a corresponding free end of a medical tube. For example, in some embodiments, the first connector 13 may include a hose connector, a female luer connector, a male luer connector, a male threaded connector, a female threaded connector, or any other suitable connector. Similarly, the patient-side element 14 includes a second connector 15 in some embodiments. The second connector 15 may be any suitable tube or hose connector configured to attach to a corresponding free end of a medical tube.For example, in some embodiments, the second connector 15 may include a spigot connector, a female luer connector, a male luer connector, a male threaded connector, a female threaded connector, or any other suitable connector. Although many forms, embodiments, and implementations are possible, this particular embodiment shown in FIG. 3 will be described in detail, while other embodiments will also be described in this application, including the combination of sub-parts into a single piece and its variations in a specific implementation of the device. The device 10 can be inserted into an existing medical port. One end may be specifically adapted to connect directly to a medical port. Other embodiments may provide alternative connections to the medical port, such as luer locks and other similar adapters. One end of the device 10 may be pre-installed on a portion of a medical port.This allows a second medical line, typically the patient-side end of the medical line with administration point 100 at patient 102, to be directly coupled to the patient-side element 14 of the device 10 via an adapter, Luer lock, or quick-disconnect coupling. However, the device 10 can be configured to couple to many existing lines, as these lines are currently usually configured with a Luer lock at the medical line end. Figure 4 shows an example embodiment of an apparatus 10 in which the pump-side and patient-side elements 12, 14 are coupled such that a fluid, gas, or solid material can pass through the apparatus 10 to be administered to a patient 102 at an administration point 100. For example, a medical provider may administer saline solution to a patient 102 through a medical line. A first line 104 can be coupled to a first connector 13 of the pump-side element 12. The saline solution would then enter the apparatus 10 through the flow inlet 16. In one embodiment, a channel 26 arranged around a shaft 24 passes through the pump-side and patient-side elements 12, 14 when the pump-side and patient-side elements 12, 14 are coupled. The saline solution flows through the pump-side element 12 to the patient-side element 14 through channel 26.A second line 106 can be coupled to a second connector 15 of the patient-side element 14. The saline solution would then flow out of the patient-side element 14 and the apparatus 10 through the flow outlet 18 in the second line 106, which would then supply the saline solution to patient 102 through the administration point 100. In some embodiments, the apparatus 10 includes at least one valve to prevent the flow of fluids, gases, or solid materials when the pump-side element 12 is uncoupled from the patient-side element 14. In one embodiment, a first valve 20 is arranged within the pump-side element 12. The first valve 20 may comprise an active valve. The active valve 20 is configured to allow the passage of fluids through the active valve 20 when the pump-side and patient-side elements 12, 14 are coupled. Thus, when the pump-side and patient-side elements 12, 14 are coupled, the active valve 20 is activated, and fluids can pass through the pump-side element 12. When the pump-side and patient-side elements 12, 14 are uncoupled, the active valve 20 is not activated, and fluids cannot pass through the pump-side element 12.This prevents fluid loss in the event of disconnection, whether accidental or intentional. A person skilled in the art will readily appreciate that a variety of active valves, including a QOSINA™ check valve, can be implemented in this embodiment. A second valve may be arranged within the patient-side element 12. This second valve 22 may comprise a passive valve. The passive valve 22 may be configured to allow flow in one direction. The passive valve 22 may also be described as a one-way valve. When fluids are pumped through the apparatus 10 from the pump-side element 12 to the patient-side element 14, the fluids may flow freely through the passive valve 22. However, if the fluids are forced through the apparatus 10 in a direction opposite to that described above, the fluids will not be able to pass through the passive valve 22 in the opposite direction. This prevents fluid loss in the event of disconnection, whether accidental or intentional. It also prevents backflow of fluids from patient 102 into the pump-side element 12 and the first line 104.Occasionally, fluid reflux from patient 102 may occur, including when an intravenous administration bag is depleted and a small amount of blood or other fluids leaks from patient 102's line, either due to pressure gradient forces or diffusion. Fluids transferred from the patient to the first and second lines 104, 106 contaminate lines 104, 106, eventually requiring line replacement. With a passive valve 22 or a one-way valve arranged in the patient-side element 14, fluids cannot flow in the reverse direction and contaminate the pump-side element 12 and the first line 104. A person skilled in the art will readily appreciate that a variety of one-way or passive valves can be implemented in this embodiment, including a duckbill valve. FIG. 5 shows an example embodiment in which a first valve 20 is arranged in the pump-side element 12 of the apparatus 10. FIG. 6 shows an example embodiment in which a second valve 22 is arranged in the patient-side element 14 of the apparatus 10. Figure 7 provides a representation of an example first valve 20 arranged in a first valve chamber 21 of the pump-side element 12 of the apparatus 10. In this embodiment, the first valve 20 is an active valve. The first valve 20 comprises a piston 28, a support base 29, and a diaphragm 30. When the first valve 20 is not actuated, the diaphragm 30 forms a seal with the inner wall 31 of the pump-side element 12, so that fluid cannot pass through the pump-side element 12. The piston 28 can be manually deflected toward the diaphragm 30 so that the diaphragm 30 is deflected from the inner wall 31 and breaks the seal between the diaphragm 30 and the inner wall 31. When diaphragm 30 is deflected from the inner wall 31, the fluid can flow past diaphragm 30, past the canton 29 and through the pump-side element 12.The diaphragm 30 can rest on a support base 29 within the first valve chamber 21. The support base 29 can be configured to allow fluid to pass from the flow inlet 16 into the first valve chamber 21. The support base 29 can also be configured to deflect the diaphragm 30 toward the inner walls 31 of the pump-side element 12 when the piston 28 is not exerting a force on the diaphragm 30, thereby creating a seal between the diaphragm 30 and the inner walls 31. The seal between the diaphragm 30 and the inner walls 31 can also result from fluid being forced from a pump into the pump-side element 12 and pressing the diaphragm 30 against the inner walls 31. The seal can result from both of the aforementioned forces. With regard to FIG. 8, an example embodiment of a patient-side element 14 arranged around a shaft 24 is shown. The patient-side element 14 further comprises a stem or cannula 32, a second valve chamber 23, a flow outlet 18, and a channel 26 running through the patient-side element 14. A second valve 22 may be disposed in the second valve chamber 23. The second valve 22 may be a one-way valve or, more specifically, a duckbill valve, which allows fluids to flow through the second valve 22 in only one direction. In one embodiment, the cannula 32 extends from the second valve chamber 23 and the flow outlet is arranged in or near the second valve chamber 23 opposite the cannula 32. In this embodiment, a fluid can enter the cannula 32 and flow through the channel 26 to the second valve chamber 23.The second valve 22, located in the second valve chamber 23, is configured to allow fluid to flow from the cannula portion of channel 26 to the flow outlet portion of channel 18. The fluid then exits the patient-side element 14 of the apparatus 10. The fluid flowing from the cannula portion of channel 26 creates internal pressure in the duckbill valve, causing it to open. When fluid flows in the opposite direction, from the outlet portion of channel 18, the external pressure on the duckbill valve causes it to close tightly. Figures 9 and 10 show an embodiment in which several components are coupled together to form a pump-side element 12 and a patient-side element 14. In some embodiments, the pump-side element 12 may comprise a female luer lock adapter 160, an actuated luer check valve housing 150, and a push-fit connector 140. In some embodiments, the female luer lock adapter 160, the actuated luer check valve housing 150, and the push-fit connector 140 may be integrated into a single unit. The patient-side element 14 comprises an anti-reconnection device 120 and a guide groove device 130. In some embodiments, the anti-reconnection device 120 and the guide groove device 130 may be integrated into a single unit. Each of these elements and the various embodiments will be discussed in more detail below. In one embodiment, the cannula 32 of the patient-side element 14 extends from the patient-side element 14. A channel 26b arranged around a shaft 24 can pass through the cannula 32 and the patient-side element 24. When the cannula 32 is inserted into the pump-side element 12, the channel 26a of the pump-side element 12 is in a sealed configuration with the channel 26b of the patient-side element 14. When the pump-side element 12 and the patient-side element 14 are composed of the various elements mentioned above as shown in FIG. 11, each element has an individual channel 26a-26e which, when each of the elements is coupled together in a sealed configuration, forms a single channel 26 through which a fluid can flow through the apparatus 10.The various components can be kept separately or can be manufactured in different combinations of unit components, except for the snap-fit ​​connector 140 and the anti-reconnection device 120. Figure 12 shows an embodiment of a non-reconnection device 120. The non-reconnection device 120 comprises a neck 121 and a stem or cannula 32. A channel 26 passes through both the neck 121 and the cannula 32. The channel 26 and the non-reconnection device 120 may be arranged around a shaft 24. In one embodiment, the neck 121 defines a second valve chamber 23 in which a second valve 22 may be placed to control the flow and direction of fluid flow through the apparatus 10. Many different valves may be placed in the chamber, but one embodiment includes a duckbill valve to control the direction of fluid flow in the apparatus 10. An anti-reconnection device 120 comprises at least one fixation arm 122. The fixation arm 122 is configured to facilitate detachable coupling of the apparatus 10, thereby allowing a medical route to be released when a force is applied to the medical route through the apparatus 10. In some embodiments, the fixation arm 122 extends from the anti-reconnection device 120 at a distal end of the neck 121. The fixation arms 122 extend from the neck 121 such that the fixation arms 133 are positioned radially outward from the cannula 32. In some embodiments, the fixation arms 122 may be substantially perpendicular to the axis 24. At a distal end of the fixation arms 122, a fixation joint 123 defines a curve in which the fixation arms 122 cease to be parallel to the axis 24 and begin to extend radially outward from the axis 24 in a angle greater than 90 degrees.Thus, a gripping surface 124 extending from the fixing arms 122 at the fixing joint 123 is at an angle 125 less than 90 degrees with respect to a radial axis 126 extending perpendicularly from the first axis 24 passing through the channel 26. See FIG. 17e and 18d. Another embodiment of the anti-reconnection device 120 may include a shield 127. The shield 127 may be arranged radially outward from the gripping surface 124 and, in other embodiments, around the fixation arms 122. The shield 127 prevents the fixation arms 122 from being intentionally or unintentionally contacted by a patient or in any other way. In some embodiments, the shield 127 defines the receiving slots 128 of the fixation arm protector. The receiving slots of the fixation arm protector 128 are configured to receive the fixation arm protectors 136, which will be described later. Figure 13 shows an embodiment of a guide slot device 130. The guide slot device 130 substantially corresponds to an anti-reconnection device 120 to form the patient-side element 14. In one embodiment, the guide slot device 130 may comprise a male luer lock 132 having chamber walls 134 extending from a distal end of the male luer lock 132, the chamber walls 134 defining a second valve chamber 23. In some embodiments, the second valve chamber 23 of the anti-reconnection device 120 and the second valve chamber 23 of the guide slot device 130 are the same chamber. The walls of each of the anti-reconnection devices 120 and the guide slot device 132 may correspond so as to form a single second valve chamber 23, as shown in Figure 14.A second valve 22 can be inserted into the second valve chamber 23 to regulate the flow and direction of fluid flow in apparatus 10. The guide slot device 130 is arranged around an axis 24 that corresponds to the axis 24 around which the anti-reconnection device 120 is arranged, such that when the guide slot device 120 and the anti-reconnection device 120 are coupled, there is a single axis 24 around which the patient-side element 14 is arranged. The channel 26 runs through the guide slot device 120. In some embodiments, the guide slot device 130 further comprises the locking arm guards 136. The locking arm guards 136 are arranged radially outward from the locking arms 122 of the anti-reconnection device 120 when it is coupled to the guide slot device 130, as shown in FIG. 14. The locking arm guards 136 act as a shield to prevent access to the locking arms 122. The locking arm guards 136 further define the guide slots 138. When a medical line is disconnected, a patient or another person may sometimes attempt to reconnect the device 10. However, this can be dangerous for the patient, as the lines may have become contaminated during disconnection.Thus, when establishing a connection, because the fixation arm protector 136 and shield 127 interfere with direct access to the fixation arm 122, it becomes inaccessible. The fixation arms 122 can only be accessed through the guide slots 138, which may be arranged in the fixation arm protector 136 or shield 127. The guide slots 138 may be configured so that the only way to access the fixation arms 122 is by using a special tool designed for those guide slots 138. This limits the ability to establish a connection between the pump-side and patient-side elements 12, 14, and ultimately, the connection between the IV line and the patient 102. Therefore, when accidental disconnections occur, a medical professional can appropriately assess the situation to determine whether reconnection is necessary due to the presence of contamination. Figure 14 shows an example embodiment of patient-side element 14. Patient-side element 14 can be manufactured as three separate sub-parts (duckbill valve 22, anti-reconnection device 120, and guide groove device 130). The sub-parts can be assembled and coupled using common techniques such as bonding materials, connectors, etc. Another embodiment can be implemented as a single unit construction of the sub-parts. This could include 3D printing techniques. However, it should be understood that the concepts disclosed here do not depend on patient-side element 14 being composed of several assembled sub-parts or being a single, unitary element. To better understand the device 10, the pump-side element 12 will be described in more detail. The pump-side element 12 provides an attachment point to which the attachment arms 122 of the patient-side element 14 can be attached, thereby connecting the pump-side element 12 and the patient-side element 14 to form the device 10. Figure 15 shows an example embodiment of the pump-side element 12. In some embodiments, the pump-side element 12 may comprise a female luer lock 160, an actuated luer check valve device 150, and a push-fit connector 140. Depending on the ports used, the pump-side element 12 may comprise various sub-parts, such as quick-connect fittings, male luer locks, bayonet fittings, compression fittings, splined connectors, flared connectors, interchangeable valves, etc. In another embodiment, the pump-side element 12 may be a single unit, and all the aforementioned components and functions, such as the female luer lock 160, the actuated luer check valve device 150, and the quick-fit connector 140, may be integrated into a single unit. Figure 16 shows an example embodiment of the snap-fit ​​connector 140. The snap-fit ​​connector 140 can be arranged around a shaft 24. The shaft 24 can pass through all the various sub-pieces of the pump-side element 12 when it is coupled and aligned with the shaft 24 of the patient-side element 14 and when the pump-side element 12 and the patient-side element 12 are detachably coupled. In addition, a channel 26 can be arranged within the snap-fit ​​connector 140. When a channel 26 and the patient-side element 14 are detachably coupled, elements 12 and 14 form a single channel 26. The press-fit connector 140 can also define a recess for an O-ring 142. This recess 142 is configured to receive an O-ring 144 in order to prevent fluid leakage when elements 12, 14 are separably coupled. An example embodiment of the snap-fit ​​connector 140 may further comprise a fixing bar 146. The fixing bar 146 is configured to receive the fixing arms 122 of the anti-reconnection device 120. In one embodiment, the relationship between the fixing arms 122 and the fixing bar 146 provides the device 10 with the detachable and anti-reconnection functionalities. In some example embodiments, the fixing bar 146 may further comprise an angled receiving surface 148. The angled receiving surface 148 may be at an angle 149 of less than 90 degrees relative to a radial axis 126 extending perpendicularly from the first axis 24. See FIGS. 17e and 18d. The angled receiving surface 148 of the fixing bar 146 and the gripping surface 124 of the fixing arms 122 are configured to be complementary to each other. In some embodiments, this may result in the angled receiving surface 148 and the gripping surface 124 being flush when the pump-side and patient-side elements 12, 14 are detachably coupled. Thus, when the pump-side and patient-side elements 12, 14 are separably coupled, the gripping surface 124 and the angled receiving surface 148 are substantially in contact.In other embodiments, surfaces 124, 128 are substantially parallel but not perfectly parallel and therefore cannot maintain a perfectly flush contact surface. In some embodiments, when the pump-side and patient-side elements 12, 14 are separably coupled, the fixing arms 122 are slightly radially inwardly deflected by the fixing bar 146. This means that the fixing arms 122 are radially outwardly inclined because the materials prefer to remain in a non-deflected state. In other embodiments, the fixing bar 146 is arranged such that when elements 12, 14 are separably coupled, the fixing arms 122 and the fixing bar 146 are in contact, but the fixing arms 122 are not radially inwardly deflected. Figures 17a-17f and 18a-18e show the process of separating and coupling the pump-side element 12 to the patient-side element 14. For the pump-side element 12 to detach from the patient-side element 14, the fixing arm 155 must pass over or release the fixing bar 146. As mentioned earlier, sometimes a patient or other circumstances can accidentally apply force to the intravenous injection tubing. This can result in the detachment of the administration site 100 from the patient 102, potentially causing extensive tissue damage to the patient 102, as well as severe pain. The complementary nature of the angled receiving surface 148 of the fixing bar 146 and the gripping surface 124 of the fixing arms 122 in some embodiments can facilitate the separability of the pump-side element 12 from the patient-side element 14.When an opposing outward axial force 170 is applied through the apparatus 10 (such as pulling on an intravenous injection tube), because the angled receiving surface 148 and the gripping surface 124 are neither parallel nor perpendicular to a radial axis 126, the angled receiving surface 148 exerts a force 172 perpendicular to the plane of the angled receiving surface 148 on the gripping surface 124 in response to the opposing outward axial force 170 applied to the apparatus 10. This force 172 is transmitted to the clamping arm 122. The clamping arm 122 will consequently deflect radially inward from the force 172 exerted by the angled receiving surface 148 as a result of the opposing outward axial force 170 applied through the apparatus 10. See FIGS. 17b and 18b.When the clamping arms 122 are deflected radially inwards, the materials of the clamping arm 122 have some elasticity and exert a radially outward-oriented force 174 in order to return the clamping arm 122 to its rest position. Once the elements 12, 14 have detached, the clamping arms 122 return to their rest position as illustrated in FIG. 18e. The opposing outward axial force 170 required to detach elements 12, 14 from the pumping side and the patient side can be modified by varying some features of the apparatus 10. First, the angle 125, 149 at which the angled receiving surface 148 and the gripping surface 124 are arranged results in different degrees of detachment resistance. See FIG. 18d. For example, if the angled receiving surface 148 and the gripping surface 124 are set at an angle close to 90 degrees with respect to a radial axis 126, the resulting force 172 is more complementary to the direction of deflection of the fixing arm 122 for release and will result in a radially inward force applied to the fixing arm 122 and will not result in an axial force on the fixing arm 122. The radial inward force will cause the fixing arms 122 to deflect radially inward.The axial force will produce tension in the clamping arms 122, but will not deflect them. The tension, on the other hand, will provide resistance to the opposing outward axial forces 170. Thus, the more parallel the angled receiving surface 148 and the gripping surface 124 are with respect to the radial axis 126, the more the force between the two components 124, 148 will be directed axially rather than radially. Therefore, a greater opposing outward axial force 170 is required to achieve an inward radial deflection of the clamping arms 122. See FIG. 17e. Second, the opposing outward axial force 170 required to achieve release can be varied by the length of the gripping surface 124. If the gripping surface 124 is longer, the clamping arms 122 must be deflected a greater distance radially inward to clear the angled receiving surface 148 and the fixing bar 146. More force is required to deflect the clamping arm 122 radially inward; therefore, if a greater or lesser amount of opposing outward axial force 170 is desired for release, the length of the gripping surface 124 can be increased or decreased, respectively. This may cause some material stress in the clamping arm 122; therefore, the clamping arm 122 may also comprise a reinforced joint 122a where the clamping arm 122 extends from the anti-reconnection device 120. Third, the texture of the angled receiving surface 148 and the gripping surface 124 can be modified to provide greater resistance. As the opposing outward axial force 170 is applied to the apparatus 10, the gripping surface 124 slides relative to the angled receiving surface 148. This sliding motion creates an opposing frictional force. The higher the coefficient of friction on the two surfaces 124, 148, the greater the opposing outward axial force 170 required to separate the apparatus 10. The surface area of ​​the two surfaces 124, 128 can be adjusted to provide varying levels of resistance. This includes larger or smaller surfaces 124, 148, or imperfect contact between the two surfaces 124, 148. Fourth, the material and thickness of the fixation arm 122 can also alter the amount of opposing outward axial force 170 required to detach the appliance 10. When the fixation arm 122 is made of a thicker, stiffer material, a greater force is required to radially deflect the fixation arms 122. Thus, the force required to decouple the two elements 12, 14 can be modified to maximize the effectiveness of the appliance 10. For certain patients or insertion sites, it may be necessary to maintain a low threshold tension or opposing outward axial force 170 to induce detachment, as the tissue or patient may be particularly susceptible to damage or have special sensitivities. Other situations may require a higher threshold for decoupling. The O-ring 144 can also provide additional resistance to decoupling the two elements 12, 14. The relationship between the clamping arms 122 and the clamping bar 146, in conjunction with the clamping arm protectors 136, provides the anti-reconnection feature described herein. The clamping arms 122 further define a deflector surface 129. When the pump-side and patient-side elements 12, 14 are uncoupled and their corresponding axes are aligned, the clamping arm 122 and the clamping bar 146 are aligned such that when the two elements 12, 14 move along axis 24 toward each other, the deflector surface 129 of the clamping arm 122 contacts the clamping bar 146. The deflector surface 129 obstructs further movement, preventing the two elements 12, 14 from coupling. In some embodiments, the deflector surface 129 is at an angle substantially parallel to the gripping surface 124.The fixing bar 146 can also be angled or rounded so that when a user applies an opposing inward axial force 171 to the two elements 12, 14 and the fixing bar 146 is in contact with the deflector surface 129, the fixing arm 122 is deflected radially outwards, thus preventing the coupling of the two elements 12, 14. Since the deflector surface 129 and the fixing bar 146 are aligned to prevent coupling when the fixing arm 122 is not deflected, to achieve coupling of the two elements 12, 14, the user must manually deflect the fixing arms 122 radially inward so that the fixing arm 122 is released and slides past the fixing bar 146 when the two elements 12, 14 are moved along axis 24 toward each other. In some embodiments, the fixing arm guards 136 prevent access to the fixing arms 122. Access is only possible through the guide slot 138. A special wrench is required to deflect the fixing arms 122 radially inward. This allows a healthcare professional to restrict the ability to couple the two elements 12, 14 to those with access to a wrench.When unintentional disconnections occur, a healthcare professional can assess the situation and determine whether the line can be reconnected or if a new line needs to be used due to contamination or damage. A person skilled in the art would readily recognize that the components described above can be arranged in any of the elements 12, 14 and can be relocated or reversed in each of the elements 12, 14. Thus, within the scope of this disclosure, it is possible to relocate the attachment arms 122, the attachment arm protectors 146, and any other parts described in this disclosure that are located in the patient-side element 14 to the pump-side element 12, and to relocate the attachment bar 146 and other associated elements located in the pump-side element 12 to the patient-side element 14. In addition, the valves 20, 22 and the activation structures (cannula 32 and activation surface 32) can reside in the opposing elements 12, 14, as described above, when fluids are withdrawn from a patient 102 instead of being administered to patient 102.In some embodiments, the two elements 12, 14 may also comprise blind end caps. These caps are configured to prevent contamination of the internal channels and components of elements 12, 14. In some embodiments, the blind end caps may comprise existing components such as the shield 127, the fixing bar 146, and the fixing arm protectors 136. In other embodiments, the second end of the patient-side elements 110 may be operated to act as a first blind end cap, and the proximal end of the pump-side element 12 may be operated to act as a second blind end cap. In other embodiments, the channel diameter 26 and the cannula 32 provide tamper protection for the valves 20, 22 of the apparatus 10.Patients, after an accidental disconnection, may attempt to reconnect the device 10 and the channel diameter 26 and the cannula 32 avoid contact with the valves 20, 22, which could cause damage to the valves 20, 22 and loss of fluids through the damaged valves. Since the apparatus 10 is used in fluid transfer applications, if a disconnection occurs, it is important that the flow of fluid through the device stops to prevent fluid loss from a patient and leakage from an intravenous bag, for example. Some embodiments may incorporate a series of valves to prevent fluid loss and the resulting cleanup and hazards of uncontained fluids. As mentioned earlier, a duckbill valve 22 may be implemented in the apparatus 10 to prevent backflow of fluids against the intended flow. The duckbill valve 22 is positioned on the descending portion of the two elements 12, 14. Other one-way valves, as well as multi-way valves, may also be implemented in other embodiments.Thus, if a patient is having fluids removed, the duckbill valve 22 would be on the pump-side element 12 downstream of patient 102, whereas the duckbill valve 22 would be near patient 102 if fluids were being administered to patient 102. As mentioned earlier, a first valve 20 is needed to prevent fluid from continuing to flow from the source once the two elements 12 and 14 have been decoupled. In some embodiments, this is achieved by providing a first valve 20 that is only active when the two elements 12 and 14 are coupled. This can be achieved by providing a cannula 32 that extends into the pump-side element 12 and activates a check valve or the first valve 20. The pressure exerted by the valve actuation surface 34 of the cannula 32 when the two elements 12, 14 are coupled activates the first valve 20. When the two elements 12, 14 separate, the valve actuation surface 34 no longer applies pressure to the first valve 20, thus preventing fluid from flowing through the first valve 20. Some embodiments may utilize a commercially available check valve, such as the QOSINA™ Luer-activated check valve. In some embodiments, an O-ring 144 may be placed inside the apparatus 10 to minimize fluid loss during uncoupling. As the two elements 12, 14 separate, the actuating surface of the valve 34 of the cannula 32 loses contact with the first valve 20. The O-ring 144 is positioned in the channel 26 so that the seal around the cannula 32 remains intact even after the first valve 20 becomes inactive. In this way, the system remains sealed for a period of time even after the first valve 20 ceases to be active, and fluids cannot pass into or through the apparatus 10. See Figures 17e and 17f. Thus, although particular embodiments of the present invention of a new and useful DETACHABLE MEDICAL TUBE CONNECTOR have been described, such references are not intended to be interpreted as limitations regarding the scope of this invention.

Claims

1. A method for coupling a separable track connector (10), comprising: aligning a first channel (26a) of a first side element (12) of the separable track connector (10) with a second channel (26b) of a second side element (14) of the separable track connector (10), wherein the first side element (12) comprises a fixing bar (146) and wherein the second side element (14) comprises a fixing arm (122), characterized in that the second side element (14) further comprises a fixing arm protector (136) extending from the second side element (14) and positioned radially outward from the fixing arm (122),wherein the fixation arm protector (136) defines a guide slot (138) configured to allow access to the fixation arm (122); inserting a key into the guide slot of the fixation arm protector (136); deflecting the fixation arm (122) of the second side element (14) radially inward; advancing the second side element (14) and the first side element (12) toward each other until the first channel and the second channel are in fluid communication; releasing the fixation arm (122) so that the fixation arm (122) of the second side element (14) engages with the fixation bar (146) of the first side element (12).

2. The method of claim 1, wherein the first side element (12) is a pump-side element (12) and the second side element (14) is a patient-side element (14).

3. The method of any of the preceding claims,wherein the step of deflecting the locking arm (122) is via the key.

4. The method of any of the preceding claims, further comprising activating a first valve (20) of the first side member (12) via a valve activation surface of the second side member (14), wherein the first valve (20) comprises a diaphragm (30), and wherein the valve activation surface of the second side member (14) is axially separated from the diaphragm (30) upon activation of the first valve (20).

5. The method of any of the preceding claims, further comprising receiving a cannula (32) of the second side member (14) in the first side member (12).

6. The method of claim 5, wherein the cannula (32) is received in an O-ring (144) of the first side member (12).

7. The method of any of the preceding claims,further comprising sliding the clamping arm (122) beyond the fixing bar (146) when the fixing arm (122) is manually deflected radially inwards.

8. The method of any of the preceding claims, wherein the fixing arm (122) and the fixing bar (146) are arranged to resist engagement when the fixing arm (122) is in a neutral position.

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